Project Summary: Quintiles Federated Services, Inc. (QFSI), part of the world's largest contract research organization, proposes to create and administer a Clinical Trials Unit (CTU) to conduct studies to support the research objectives of the NIAID HIV/AIDS Clinical Trials Networks. The CTU will participate in three high-priority research areas: translational research/drug development, optimization of clinical management, and vaccine research and development. At full capacity, the CTU will maintain 150 patients/month on study in drug development, 110/month in optimization of clinical management, and 60/month in vaccine development. QFSI will serve as the CTU administrative unit. Community-based HIV care sites in Philadelphia, Washington (DC), northern Virginia, San Francisco, and Los Angeles will be led by highly experienced investigators with a proven track record of enrolling large numbers of patients (including underserved populations) into commercial and community-based clinical trials and obtaining high-quality data. Sites in Guatemala, Honduras, Costa Rica, and Panama will provide a unique opportunity to carry out clinical studies in an area that is a leading edge of the HIV pandemic. Investigators and staff at these Central American sites are highly trained and committed to becoming an integral part of NIAID's research program. The local populations will benefit by having access to NIAID-sponsored clinical trials, the clinical research infrastructure in Central America will thrive, and data from such studies stand to advance the clinical science that underpins the optimal care of HIV-infected individuals. Dr. Kathleen Squires, a renowned clinical scientist at Thomas Jefferson University, in Philadelphia, will serve as the co-principal investigator to provide scientific liaison between the CTU and the Network Leadership organizations for matching studies with sites. Relevance: As the global number of individuals living with HIV continues to rise, there is an urgent need to develop potent anti-HIV drugs with novel mechanisms of action, that are active against drug-resistant HIV strains, and that are less toxic and easier to take. There is also an urgent need to better understand how to best use currently available drugs in different stages of disease, in different patient populations, and in treatment-experienced vs. treatment-naive individuals. To help the Clinical Trials Networks address these issues, the Quintiles Federated Services CTU will bring fresh scientific ideas and new patient populations. ADMINISTRATIVE COMPONENT: